The National Heart, Lung, and Blood Institute (NHLBI) convened a Working Group (WG) of invited external experts in heart, lung and blood research and clinical research oversight, bioethics, health economics, regulatory matters and information technology for a meeting June 28-29, 2011.  The purpose of this Working Group was to explore and discuss existing information and metrics on alternative Institutional Review Board (IRB) models and to discuss optimization of the IRB review process as one way to facilitate the conduct of NHLBI-funded human subjects research.  An IRB review process executive summary is available on the NHLBI website.